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Institutional review board (IRB) review is required for all federally funded research involving human subjects regulated by the Food and Drug Administration, or performed at an institution that accepts federal funds. The requirement to document IRB review and the procurement of informed consent (IC) in published research reports is more recent. This chapter examines to what extent research published in three peer-reviewed pediatric journals documented IRB approval and IC, and to what extent the researchers who failed to document IRB and IC stated that they had obtained appropriate IRB review and consent from subjects. It was observed that a small but significant number of pediatric research protocols failed to obtain IRB approval or a waiver.

This chapter describes the committees responsible for reviewing proposals to conduct research involving humans as subjects to determine whether they include adequate safeguards of the rights and welfare of the research subjects. These committees, generally called institutional review boards (IRBs), now exist in many locales in most countries. National regulations in an increasing number of countries and the leading international codes of research ethics establish the requirement that research involving humans as subjects, with few exceptions, may not be carried out without review and approval of these committees; hence their importance to epidemiologists. The history, composition, organizational settings, purposes of these committees, and major themes in contemporary controversies about them are discussed.

This chapter discusses some problems with the current U.S. system for protecting human research subjects. These problems indicate that in some ways the regulations provide too much oversight, in others too little. Examples of too much oversight include excessive paperwork, the review of low‐risk research, and an overly broad definition of research; examples of too little include inconsistencies and loopholes in the regulations, lack of compensation for injuries, inconsistent adverse event reporting, and lack of broad research review. Federal regulations and guidelines for research should be revised so that there is more emphasis on protection of human subjects and less emphasis on bureaucratic, administrative, and technical/legal issues. Although the current system has some problems, it has operated very well for more than three decades. In many ways, the institutional review board (IRB) system represents a judicious compromise between government oversight of human research and scientific autonomy. While there is no need to overhaul the system, changes should be made to improve the quality, scope, effectiveness, and fairness of research review and oversight.

In most developed countries, current standards for the responsible conduct of research with human subjects derive from the Nuremberg Code. It has been amplified in the Belmont Report, which is the basis of federal guidelines (known as the common rule) for research using human subjects. Each institution that conducts research on human subjects must submit an assurance that guarantees compliance with federal policy. No research project involving human subjects may proceed without an approved assurance on file. Federal policy also requires the establishment of an institutional review board (IRB) to review all proposed and ongoing research projects involving human subjects. The IRB has the authority to approve human subject research protocols. Federal policy dictates IRB membership criteria. Some universities use independent, for-profit IRBs to review protocols. Guidelines for expedited and exempt protocol reviews are described. The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accredits institutional human research protection programs, including IRB activities. The chapter concludes with an analysis of current federal regulations on research using human embryonic stem cells.

The protection of human subjects in research, the regulations that govern the use of human subjects, and the role of the IRB in carrying out those regulations have been the subject of much discussion among social scientists. This chapter presents information on the ethical and practical considerations in using human subjects in social science research. It examines the principles underlying the current regulatory system, what they mean for social behavioral research, and how those conducting such research might best work within the Institutional Review Board (IRB) system. It will pay particular attention to conducting research with vulnerable populations, and protection issues related to community-engaged studies. The chapter also presents information about the implications of the Health Insurance Portability and Accountability (HIPPA) Act for social science research.

This chapter begins with a chronology of requirements/guidelines pursuant to research on human beings, with emphasis on clinical trials. It then describes institutional review boards (IRBs) and IRB membership requirements.

This chapter aims to eliminate the need for others to learn by trial and error. The practical issues addressed here range from the process of explaining a population-based experiment to the Institutional Review Board (IRB), to the issue of maximizing the effectiveness of a treatment in a population-based experiment. Different disciplines had different problems adapting to the idea of a population-based experiment, and the chapter uses various war stories to illustrate the kinds of problems most likely to plague users from different disciplines. The challenge of producing effective treatments involves simultaneously increasing the extent to which the independent variable is varied and reducing measurement error. Consideration of ethics and human subjects comes into play because there are important limits on what investigators can do by way of manipulation in the context of surveys.

Medical research, and specifically clinical trial research on human subjects, is necessary to make advances in medicine. Such research depends on high levels of trust between the subjects and the physician scientists conducting the trials. This chapter addresses the erosion of public trust in health research, its causes and consequences, and some solutions. Abuses of the past have left a broad legacy of mistrust. Government regulation attempted to impose better procedures to ensure good medical ethics. Institutional Review Boards were formed to monitor federally funded research. However, patient mistrust and conflicts of interest by researchers remain concerns in the field. The chapter recommends moving from a culture of compliance to a culture of conscience, in which people act responsibly because it is the right thing to do. In addition, it discusses the importance of providing incentives for good performance.

This chapter explains the role of research administrators in providing leadership and expertise in supporting faculty grant applicants by addressing all the administrative aspects of the pre and post award activities. These activities may include supporting the investigator in navigating the complex system of university sponsor, state and federal regulations. Details are provided about the role of the office of sponsored research within a university, developing budget justifications, policies and practices around indirect rates, human subjects, effort certification as well as preparation of expenditure reports.

Summing up the book, this chapter reviews the argument, notes the novelty of the partial-entrustment model and, looking forward, sets out practical steps that can be recommended even without committing to that approach. The partial-entrustment approach is shown to be an important addition to the bioethical principles set out by Beauchamp & Childress (2009) and Emanuel et al. (2004) and to evade worries about paternalism raised by Wertheimer & Miller (2007). Further, the idea of moral entanglements on which it rests is of interest, more broadly, to moral philosophers. Regarding practical steps that need to be taken, the “four Ps” of a 2008 consensus paper by participants in a Georgetown ancillary-care workshop are reiterated and reinforced, along with their framework of three key questions for Institutional Review Boards and Research Ethics Committees.

Child-centered inquiry has been influenced by a variety of sources. A central notion is that children should be studied as social actors in their own right. This idea was especially propelled by the United Nations Convention on the Rights of the Child held in 1989, giving way to methodological innovation around the globe aimed at exploring children’s concerns and salient issues. A core dilemma of child-centered methods concerns whether investigators should take on completely child-like roles during research (“least-adult”), or alternatively act out a more mature stance in the course of seeking connection with children. This dilemma ties to common calls for reflexivity by the researcher and active participation by the young. Ironically, while children sometimes participate as active co-researchers in child-centered inquiry, under current U.S. Institutional Review Board (IRB) practices, they are given only secondary status in consenting to a study.

This chapter addresses how grounded theory is affected by a variety of recent developments in social work research. These include a discussion of why it is sometimes difficult to conduct a grounded theory study today, and what to do when you want to develop theory but it is impractical to apply the grounded theory method. The chapter also considers ethical and institutional review board issues in grounded theory research. Attention is given to the practical considerations of publishing formats for grounded theory studies, with illustrations from exemplar grounded theory studies. It also discusses the use of computer software programs in grounded theory analysis. It considers the use of grounded theory in mixed method research. Finally, it discusses “formal grounded theory,” the grounded theory model for synthesizing qualitative studies. Exercises designed to help readers apply the material in the chapter to their own research are provided.

This chapter examines conflicting norms in the government's licensing of speech and the press on “human-subjects research” through institutional review boards (IRBs). It begins by discussing licensing and why the prohibition of it is so fundamental and prroceeds by providing an overview of the structure of institutional review board licensing. It then highlights the unconstitutionality of IRB laws, arguing that the use of IRBs violates the principles of academic freedom. It asserts that licensing of speech or the press was a method of controlling the press employed by the Inquisition and the Star Chamber, and the First Amendment unequivocally barred it. Particularly in medical research and its publication, the suppression evidently causes several thousands of deaths each year. The chapter considers the IRB censorship to be the most widespread and systematic assault on the freedom of speech and the press in U.S. history.

This chapter examines the importance of local precedents in the decision making process of institutional review boards (IRBs) based on a survey of the chairman of IRBs in major research universities in the United States. It explains that IRB members identify new problems somewhat idiosyncratically and they develop remedies for these problems by drawing on warrants of experts. It suggests that the way the IRB works resonates with what it called analogical reasoning which was developed in Anglo-American law and medicine during the late nineteenth century.

This chapter outlines the challenges of obtaining institutional review board (IRB) coverage for community-based participatory research (CBPR) projects. Community-based participatory research focuses on problems that affect whole communities and thus is different from most biomedical research, which takes the individual as its primary subject. In CBPR projects, researchers work closely with community members and community-based organizations to develop appropriate research agendas, conduct analyses, and disseminate results and information. In general, IRBs are unfamiliar with this approach to research, reluctant to take responsibility for the actions of community partner organizations, and resistant to interaction between researchers and participants. Their hesitation causes significant delays and may prevent effective research and dissemination of results. The chapter then suggests concrete ways in which IRBs and funders can develop clear review guidelines that respect the unique qualities of CBPR.

This introductory chapter discusses the theme of this volume which is about the role of institutional review boards (IRBs) in designing the U.S. government rules for the treatment of human subjects in research after World War II and the present-day consequences of their choice to adopt review procedures rather than ethics principles. This volume is divided into two main sections. The first section offers an analysis of actual IRB meetings and the second explains how the moral authority to decide how to treat research participants was relocated from professions to the state and reinvested in procedures rather than ethics principles.